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Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction (MELODY-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02070991
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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Brief Summary:
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Macitentan Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : November 1, 2015
Actual Study Completion Date : November 1, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Macitentan

Arms and Interventions
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Arm Intervention/treatment
Experimental: Macitentan
oral tablet, 10 mg once daily.
 Drug: Macitentan
oral tablet, 10 mg once daily
Other Name: ACT-064992
Placebo Comparator: Placebo
Matching placebo, once daily.
 Drug: Placebo
matching placebo
Other Name: matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment [ Time Frame: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day ]
    The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.


Secondary Outcome Measures :
  1. NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  2. PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest [ Time Frame: From randomization up to end of treatment period (Week 12) ]
    Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC).

  3. Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  4. Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  5. Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP) [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  6. Change From Baseline to Week 12 in Cardiac Index (CI) [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  7. Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG) [ Time Frame: From randomization up to end of treatment period (Week 12) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and Females >=18 years of age
  2. Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
  3. Optimized diuretic therapy

Exclusion Criteria:

  1. Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
  2. Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070991


Locations
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Sponsors and Collaborators
Actelion
Investigators
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Study Chair: Sébastien Roux, PhD Actelion
More Information
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02070991    
Other Study ID Numbers: AC-055G201
First Posted: February 25, 2014    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019
Last Verified: April 2019
Keywords provided by Actelion:
pre- and post-capillary pulmonary hypertension
CpcPH
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Ventricular Dysfunction
Ventricular Dysfunction, Left
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Heart Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists